Trial Outcomes & Findings for Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma (NCT NCT01472562)
NCT ID: NCT01472562
Last Updated: 2024-07-16
Results Overview
The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
30 months
Results posted on
2024-07-16
Participant Flow
Participant milestones
| Measure |
All Patients
Study Treatment Arm
|
|---|---|
|
Induction Phase (Week 1- 48)
STARTED
|
38
|
|
Induction Phase (Week 1- 48)
COMPLETED
|
27
|
|
Induction Phase (Week 1- 48)
NOT COMPLETED
|
11
|
|
Maintenance Phase (Week 49 to PD)
STARTED
|
27
|
|
Maintenance Phase (Week 49 to PD)
COMPLETED
|
4
|
|
Maintenance Phase (Week 49 to PD)
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
All Patients
n=38 Participants
Study Treatment Arm
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsThe primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.
Outcome measures
| Measure |
All Patients
n=33 Participants
Study Treatment Arm
|
|---|---|
|
Overall Response Rate
|
92 percentage of patients
Interval 78.0 to 98.0
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment.
Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to the next treatment will be assessed by Kaplan-Meier survival analysis.PFS will be defined as the time from the first treatment day until objective or symptomatic progression or death. The outcome measure is the number of participants who achieved PFS.
Outcome measures
| Measure |
All Patients
n=36 Participants
Study Treatment Arm
|
|---|---|
|
Number of Participants With Progression-free Survival
|
21 participants
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment.
Secondary endpoints of progression-free survival (PFS), overall survival (OS), and time to next treatment will be assessed by Kaplan-Meier survival analysis. Overall survival will be defined as the time from first treatment day until death. The outcome measures is the number of participants who achieved OS.
Outcome measures
| Measure |
All Patients
n=36 Participants
Study Treatment Arm
|
|---|---|
|
Number of Participants With Overall Survival
|
24 participants
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Data was not collected on this outcome measure
Median amount of time (in months) from start of study treatment to next treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 yearsPopulation: We enrolled a total of 38 patients (all evaluable for safety), but only 36 were evaluable for responses. Two patients could not be evaluated because they had an inflammatory syndrome ("tumor flare") during the first cycle and were withdrawn before response assessment.
Outcome measures
| Measure |
All Patients
n=38 Participants
Study Treatment Arm
|
|---|---|
|
Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment
|
38 Participants
|
Adverse Events
All Patients
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=38 participants at risk
Study Treatment Arm
|
|---|---|
|
General disorders
Fever
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Basal Cell Carcinoma
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Gastrointestinal disorders
Cholangitis
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Melanoma
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Merkel Cell Carcinoma
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Pneumonia
|
5.3%
2/38 • Number of events 2 • The average time of Ae collection over all the patient is 6 years
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Tumor Flare
|
5.3%
2/38 • Number of events 2 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increase
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Injury, poisoning and procedural complications
Infusion Reaction
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritic Rash
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Shortness of Breath
|
2.6%
1/38 • Number of events 1 • The average time of Ae collection over all the patient is 6 years
|
Other adverse events
| Measure |
All Patients
n=38 participants at risk
Study Treatment Arm
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
39.5%
15/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
60.5%
23/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
73.7%
28/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increased
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
60.5%
23/38 • The average time of Ae collection over all the patient is 6 years
|
|
Renal and urinary disorders
Urinary tract Infection
|
18.4%
7/38 • The average time of Ae collection over all the patient is 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
39.5%
15/38 • The average time of Ae collection over all the patient is 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.9%
3/38 • The average time of Ae collection over all the patient is 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Infection/ Lung Infection
|
13.2%
5/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
5.3%
2/38 • The average time of Ae collection over all the patient is 6 years
|
|
Gastrointestinal disorders
Constipation
|
44.7%
17/38 • The average time of Ae collection over all the patient is 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.3%
21/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Nausea
|
31.6%
12/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Vomit
|
13.2%
5/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
28.9%
11/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hyperalbuminemia
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.7%
17/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.6%
12/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.9%
3/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
19/38 • The average time of Ae collection over all the patient is 6 years
|
|
Renal and urinary disorders
Elevated Creatinine
|
21.1%
8/38 • The average time of Ae collection over all the patient is 6 years
|
|
Cardiac disorders
Hypertension
|
15.8%
6/38 • The average time of Ae collection over all the patient is 6 years
|
|
Endocrine disorders
Hypothyroidism
|
15.8%
6/38 • The average time of Ae collection over all the patient is 6 years
|
|
Endocrine disorders
Hyperthyroidism
|
7.9%
3/38 • The average time of Ae collection over all the patient is 6 years
|
|
Hepatobiliary disorders
Elevated Alanine Aminotransferase
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
Hepatobiliary disorders
Elevated Aspartate Aminotransferase
|
28.9%
11/38 • The average time of Ae collection over all the patient is 6 years
|
|
Hepatobiliary disorders
Elevated Alkaline Phosphatase
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Fever
|
57.9%
22/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Fatigue
|
73.7%
28/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Night Sweats
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Dyspnea
|
28.9%
11/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Sore Throat
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Cough
|
55.3%
21/38 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Nasal Congestion
|
31.6%
12/38 • The average time of Ae collection over all the patient is 6 years
|
|
Skin and subcutaneous tissue disorders
Macro Papular
|
65.8%
25/38 • The average time of Ae collection over all the patient is 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
10/38 • The average time of Ae collection over all the patient is 6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.4%
7/38 • The average time of Ae collection over all the patient is 6 years
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
15.8%
6/38 • The average time of Ae collection over all the patient is 6 years
|
|
Musculoskeletal and connective tissue disorders
Gout Flares
|
10.5%
4/38 • The average time of Ae collection over all the patient is 6 years
|
|
Nervous system disorders
Dysgeusia
|
18.4%
7/38 • The average time of Ae collection over all the patient is 6 years
|
|
Nervous system disorders
Dizziness
|
21.1%
8/38 • The average time of Ae collection over all the patient is 6 years
|
|
Nervous system disorders
Neuropathy
|
15.8%
6/38 • The average time of Ae collection over all the patient is 6 years
|
|
Nervous system disorders
Tinnitus
|
13.2%
5/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Abdominal Pain
|
23.7%
9/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Head Pain/Headache/Migraine
|
26.3%
10/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Rigors
|
10.5%
4/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Edema
|
42.1%
16/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Chills
|
13.2%
5/38 • The average time of Ae collection over all the patient is 6 years
|
|
Blood and lymphatic system disorders
Tumor Flare
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
Product Issues
Infusion Related Reaction
|
34.2%
13/38 • The average time of Ae collection over all the patient is 6 years
|
|
General disorders
Serum Sickness
|
7.9%
3/38 • The average time of Ae collection over all the patient is 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place